The Future of BioPharma blog provides timely coverage of news that directly impacts the business strategies of the biotech, pharmaceutical and medical device industries. In addition to news coverage, the Future of BioPharma blog features live event coverage from IIR's Biopharmaceutical and Healthcare division.
Now in its 11th year, Immunogenicity for Biotherapeutics is THE longest running and THE largest event designed by and for the scientists who are driving progress and innovation in immunogenicity studies. The industry’s leading experts and scientists gather annually to discuss updates on emerging regulatory guidances, industry white papers, and exchange novel case studies and technology dedicated to drive forward the science, as well as, the discovery of solutions to the year’s top immunogenicity challenges.
Join us for THE immunogenicity event of the year to collaborate with the Elite Scientific Community Driving Innovation in Immunogenicity Screening and Characterization Strategies and Pushing Forward Regulatory Standardization and Global Best Practices.
Moderator: Les Funtleyder, Healthcare Strategist, Miller Tabak & Company and Author Healthcare Investing: Profiting from the New World of Pharma, Biotech, and Health Care Services Elaine V. Jones, PhD, Executive Director, Venture Capital, Worldwide Business Development, Pfizer, inc. Brett Zbar, MD, Partner, Aisling Capital Art Pappas, Managing Director, Pappas Ventures Joyce Lonergan, Former Partner, SR One, Chiron and President, The Pine Cone Company
How is the environment for deal making in drug delivery? One panelist: Venture funding dried up. They looked to take care of their current portfolio, so the bar for current investment went up. Inside lead financing went on instead of looking to the outside. In 2010, companies holding their breath can’t do this forever.
From the venture side, they’re looking to add more cash. Most corporate venture capitalists look to have strategic vent to investing. Those who’ve done it for some time would like to make a return for investors. Funding proposals weren’t accepted warmly.
The investor that in 2009, it was interesting because: they closed their fund, and although they thought they’d be cautious, they had four deals last year. In certain situations they found it hard to say no to outstanding opportunities. They’ve got quite q few new deals, if the right kind of innovation is presented.
How are evaluations? Are stocks going down or are they stable? -In 2009, most companies avoided financing. They sent that question into 2010 expecting things would improve. -Looking at a private company, private and public valuations don’t adjust the same. If someone is going out to invest money, the valuation question should be approached appropriately. There is conversation, investors look at the fundamental case and how can business be built? Then valuation should be approached? -The world has changed, things are worth half. One structural challenge is that venture capitalists don’t know what they’ll get rewarded for. It use to be positive Phase II and Phase III data, but it’s currently an unknown.
Other notes from the session: *Always know how much capital is required to develop a profit. *If you're going to a market with a product that already has a generic in the area, be sure to have the reason why your product will be able to surpass it in sales *Do hard experiments at the beginning of your product testing, and make sure it's done effectively. Be able to construct clear answers for your investors as as opposed to meso-answers.
What are other areas that are currently interesting to venture capitalists? -Biologics/biosimilars and delivery designs -Value added biosimilars -Delivery of vaccines -Novel antibody scaffolds -Pain treatments -Syringes -Ophthalmology
Share this article with your social network, just click below to share now!
Moderator: Cyndy Nayer, President and Chief Executive Officer, Center for Health Value Innovation Thom Stambaug, VP and Chief Clinical Officer, Pharmacy Management, CIGNA Peter F. Hayes, President Healthcare Solutions, Hannaford Brothers and Chair, Maine Business Coalition Kevin O’Brien, Chief Executive Officer, Partners in Care
Value based design. Getting people engaged in the appropriate care to manage chronic condition that costs employer lots of money.
Three principles: -Can we influence waste reduction? -Can we get ahead of future risk? -How can we link health to wealth and performance? How does this influence community health?
Potential partners for adherence and persistence Virtual care networks
Patients: what is individual responsibility to the health? -Accountability, good choice, health based status. How do we get the patients engaged to start taking care of themselves. If they’re not, should they be paying more into the system? A day will come when employers think about what therapies will be included on plans. What can we afford? Retail pharmacies, employers, and the global market place will probably change pricing structure.
Questions: What is new now? Why didn’t we do public healthcare ten years ago? When we look back, how do we purchase drugs? On rebates. How do rebates work? Cereals put on racks based on pricing. This is an equation for how drugs work. Can we get more performance and productivity out of every dollar that we spend? Health outcomes and productivity have to be looked at together. When we encourage patients to be compliant, the price of their care goes dramatically down because their care is better. Generics is encouraging the industry to look at this again. How can we present value for new products?
Incentives in system encourage sick care instead of healthcare. Q: How long will it be before the consumer actually knows how much the drug is costing? When you go to the doctor, you pay $30, however, it actually costs the healthcare company $200. The panelist believes that the consumer will be seeing how much different things cost via different avenues within the next 12-18 months. The market place should also provide the value of the care. Value and cost of treatment will soon be available to the customer. Total cost must be known by the consumer, as healthcare knowledge should know price and value.
Huge trend in smaller employers to a co-insurance instead of a co-pay. People are realizing what it costs. Electronic medical records will show gaps in care. The doctors own electronic medical records. So what about the individuals? They don’t own them.
Share this article with your social network, just click below to share now!
Chris Anderson Author The Long Tail: Why the Future of Business is Selling Less of More and Free: The Future of a Radical Price
Chris begins the presentation by demonstrating the end of the blockbuster. He issues this in with the N Sync No Strings Attached CD, which is the best selling CD of all time. It was the last real blockbuster in music. It hasn’t been updated in the last few years, but blockbuster albums have essentially fallen off a clip in the 2000s. The demand for music is not down, the record labels are having trouble. Music playing devices, concerts, and licensing is very high. It’s now a fragmented market. There are 10 million tracks on iTunes. We’re seeing a different music landscape, and music does not fit all, techno, pops, blues, and we all choose our distinctive taste.
Supply was confused with demand, this was one example. We accept what we’re given, until the 20th century market choices have expanded from 10 to 100 choices. Demand is shaped like a bell curve, try to find a middle ground to appeal to the most customers. The Long Tail curve actually fits it better.
Long tail graph as opposed to the long tail curve: Doesn’t have an average, it goes on forever We find that a few things are really popular, and many things are not as popular, but still appeal to a specific crowd.
The culture we grew up in was dominated by blockbuster products. This is what the retail channels want. Example: at Walmart, if two don’t sell a week, it falls off the shelves. The internet has changed business, it has infinite shelf space. The long tail has been extremely lengthened, and consumer can really find and choose what they want. With the Blockbuster industry of music, about 40% of the market was not seen.
Long tail rules: 1) If you lower the cost of creation and distribution, you can offer more products and variety. 2) “More Variety” means products are available to satisfy more minority tastes 3) There Is lots of room at the bottom for many different individualized tastes to be filled.
What does this mean for Pharma? -Blockbusters are now Niche Busters. One size doesn’t fit all, and while niches haven’t been economic to date, they can better fulfill the market. The Pharma market is going to have to follow suite. -Diagnostic boom of individualized patents. Companies are finding out the uniqueness of individuals. -Electronic Medical Records. These allow for better targeting and treatment -Informed/empowered patients – Informed can demand more specialized care. Patients can see more information, which empowers them, and can better characterize their individual needs.
Sometimes, we have to give something for free. Even though healthcare is expensive, DNA sequencing cost is decreasing in much the same why as computer chips have over the years. Free goods are not new to Pharma. It’s the patent work that is expensive to obtain, but producing the finished pill as a good costs significantly less. The cost of obtaining biology information is decreasing, so what will Pharma do to make up for the shifted revenue?
Share this article with your social network, just click below to share now!
Judith Kornfeld Vice President of Business Development TransPharma, Inc.
They’re focusing on developing products that are delivered with unique transdermal delivery. It’s the company’s lead product.
The transdermal delivery system’s ease of use points: -Convenient handling by the patient -Room temperature storage -Ready for use -Easy administration -Portable -Picket size product -No device maintenance
Two patches: printed patches and matrix patches Current products: ViaDerm hPTH1, ViaDerm-GLP1 (in pipeline)
There are currently 4 clinical trials in the pipeline: -Positive experience with patients -Strong clinical data -scaled up manufacturing lines
Share this article with your social network, just click below to share now!
Pump vs Patch Pump: -Control of timing -Any liquid formation -Blousing -Large
Patch: -Convenience -Ease of use -Small/discrete -Limited formulations
When using this patch, the history of drug delivery can be recorded, and most drugs can be put on the patch. The value proposition lies in having a lot of different drugs available. There is 85-90% efficiency of drug projection.
Share this article with your social network, just click below to share now!
In terms of drug delivery market growth, the dynamics have evolved. The world’s population growth of those who are taking medication is on a steady growth path. What’s growing it? The middle income in the emerging market is important. Individuals are quickly moving towards middle income. In India, the population is in the urban areas. In France, individuals aren’t worrying about paying for medication. In India, the purchases of Pharma are from the individuals.
Companies are going into emerging markets. It’s important to put a strategy in place when a company is looking into joining a developing market. Look at your market research: what is the patient population, knowledge and habits? What are the pricing points?
In terms of execution, use third party market research. Also, find someone in the country that can help you make the relationships to know the country.
What about the right market data for a company looking to enter an emerging market? A company should look at:
-Is the country’s population large and growing? Is the population willing to pay out of pocket for their medications? -What is the purpose of market research?
To understand and collect data you should look at: -Who are your customers: what are the prescribing habits in these markets? -Understand your competitors. -Understand your market. In Brazil and China, nurses roles are minimal.
Primary Market Research: Validate the secondary market research. If controlled or sustained release, there are two types of research. Qualitative: understand perceptions and barriers of the native population. Quantitative: Data driven, what is the relationship among the variables: pricing, position, promotion, and distribution channels.
Are there difference in the primary market b/w developed countries between developed and emerging countries?
For combination product, it depends on the product. Local and regulatory guidelines differ greatly in the local country, so it depends on the local rules in emerging market.
Which emerging market is key to 2010? The BRICK Markets. They see a fast emergence in the middle income, which is a premium driver for payment of premium markets. There’s also an increase in regulation in the countries, in addition infrastructure. Russia, Turkey and Korea were sidetracked with the economic crisis.
The country ignored in the BRICK is South Africa. Economy is growing fast, but in terms of ease, the local companies in south Africa understand the regulations. Turkey, with it’s 80m population, it’s preparing to join the EU. The increase in middle income is very large.
Share this article with your social network, just click below to share now!
Christof Boehler, PhD Chief Executive Officer Pantec Biosolutions AG
The target component to address in this case is the epidermis. The hand held device creates the micro-pores. They can control the accurate array of micro-pores. It’s without pain and causes small amounts of damage. It is independent of the skin condition.
Regulatory and intellectual property estate. One product: IVF001, IVF002, both for infertility. They can get the protein across the skin at therapeutic levels. The protein can be delivered from the patch at therapeutic concentrations.
The delivery of vaccines – application of ovalbumin using P.L.E.A.S.E. ® lead to activation of APCs. The immunization with recombinant proteins using please is superior to interdermal needle injection.
Share this article with your social network, just click below to share now!
Moderator: Stanton R. Mehr, Publisher, The Medical Pipeline Steven Avey, Vice President, Managed Care, PartnerSrx C. Daniel Mullins, PhD, Professor, Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy Scott Thompson, President, Pharmaceutical Practice, The Benfield Group Raulo S. Frear, Pharm.D., Director, Pharmacy Services, The Regence Group
The Pharmaceutical Pipeline There is an active pipeline development for compounds in the United States. Of the compounds in development, cancer is one of the top focuses. Are more compounds in the pipeline or are there slower approval rates by the FDA?
Product Value Categories of products on the market for Regence Rx: Effectiveness, safety, cost, persistency, convenience, me too product, no additional value. Over the last four years, the majority of the products have been classified as me too products or no additional value.
A few examples from the presentation: Velaglucerase (Shire) -What is it? Human cell line enzyme -What does it do? Enzyme replacement therapy -Likely indication: Type 1 Gaucher Disease
Data to date (8.3.2009) -25 treatment native patients with Type 1 Gaucher disease -2 doses administered -Endpoints met (hemoglobin, platelet counts, spleen size) -When do we expect to see it? 2Q-3Q, 2010 -What is the competition? Cerezyme (supply issues)
Fingolimond (Novartis) -What is it? Immunosuppressant -What does it do? Prevents egress of lymphocytes from lymph nodes -Likely indication: Relapsing remitting multiple sclerosis
Share this article with your social network, just click below to share now!
The 2010 DDP Awards were given out today. They were chosen by the voting of the 2010 Drug Delivery Partnerships Attendees. We would like to thank the nominees who joined us at DDP 2010 for the awards ceremony!
2010 DDP Award Winners: Pipeline Value Creation: Halozyme Therapeutics Partnering Excellence: Eurand Technology Innovation: Elan Drug Technologies
Share this article with your social network, just click below to share now!
Vik Seoni, Vice President, Business Development, Endo Pharmaceuticals Robert Bloder, Vice President, Business Development, Aveva Drug Delivery Systems, Inc.
*A few of the products mentioned during this presentation:
New Product Approvals: Last year was an eventful year in the marketplace, the approvals that came in the fourth quarter. Nucynta was approved. It’s immediate release and it’s for moderate to severe acute pain in patients >18 years of age. There is also another product in the pipeline that has tamper resistant elements.
Qutenza – 8% capsaicin patch. First and only prescription for neuropathic pain associated with PHN. Single application can reduce pain for up to 12 weeks. Also approved in Europe where Astellas will market. The product application will be interesting. It’s not a patch to wear and walk off with, there is a several hour procedure where the product is applied. Once the application process finished, you can wear the product for several weeks.
Pennsaid – Covidien Topical solution for diciofenac, for the signs and symptoms of OA of the knee. Pennsaid Plus Gel is the follow-on product in development.
Onsolis – Meda Fentanyl in BEMA delivery technology for treatment of breakthrough cancer pain in patients tolerant of opiods -REMS program -Distributed to patients through specialty pharmacies via courier -Patients receive a call from healthcare professional to ensure proper use
Share this article with your social network, just click below to share now!
Philip L. Smith, PhD, Founder PNPSmith Associates Consulting, Inc.
Joyce A. Lonergan, Founder The Pine Cone Consulting Company, Inc.
Robert Hayes, Ph.D., Venture Leader, Centyrex Johnson & Johnson Ventures
Robin Hwang, Executive Director, Head of Drug Delivery Halozyme Therapeutics, Inc.
Nicholas C. Nicolaides, President, Chief Executive Officer, Morphotek, Inc.
When you have antibodies in high concentration, it’s difficult in terms of penetration. The syringe-ability is very difficult. There are ways to try to ease the delivery of antibodies. There are quite a few device companies who are trying to develop delivery devices. One must balance flow rate, volume, viscosity, and needle gauge determine device types.
Therapeutic antibodies are continuing to expand. Scaffolds have a promise of increasing the range of applications. Delivery still has quite a bit of future improvement.
Combination product and regulatory hurdles: It’s not as difficult as it was, but now there are a few combination products that can be prescribed. There are many places you can clarify the regulatory pathway, and it’s not as difficult as it used to be.
Route administration: What role will devices play? Product and indication specific. Antibodies developing for infectious disease. The development plan must to show the product is active. IV administration is this way. Once experienced in man, you can then demonstrate if it’s effect.
Share this article with your social network, just click below to share now!
Eric Tomlinson, PhD Chief Executive Officer Altea Therapeutics
Transdermal, one normally thinks that the drug is delivered by a patch to the skin. Altea has found clinically proven transdermal delivery technology for water-soluble small drugs, biological and vaccines.
Why have a transdermal patch? -Painless delivery -High patient compliance -Improved safety -Life cycle management -Expedited regulatory patch
The skin is all dead cells, and they’re interspersed with lipids. The outside layer is the barrier for transdermal delivery other than small transdermal drugs. They work to create subtle channels to introduce the drugs into the skin.
The PassPort® System painlessly creates microscopic channels in the dead outer layer and positions a transdermal patch over the channels. The removal of the outer layer of the skin creates channels to mass transfer drugs. They can be up to 12 square centimeters. The PassPort® has dose reminder features.
Delivery capabilities: 3 Features of a drug: Molecular size (300 kDa), Aqueous solubility (300 mg/mL), Dose achieved per single application.
Patient benefits include high patient compliance with transdermal patches and broad application to water-soluble drugs.
Share this article with your social network, just click below to share now!
Josef Bossart, PhD Managing Director BioNumbers LLC (Moderator)
Are we going for more difficult products, or are there more rookies in the game? The time for drug approval has significantly increased. DDEP has increased steadily over the years. The FDA is not the problem when it comes to approval times. The median average is about eleven months for FDA approval. If the data is poor, the FDA will send you back. The FDA is not the problem in drug delivery approvals. If you’re a drug development company, you should have 4-6 products in the pipeline in order to get one approved.
Many companies believe that $15 million to the MDA submission. There are $228 million dollars to get products developed in the early 1990s. Now that coast for DDEP is about $85 millions. The direct cost when risk is adjusted is $160 millions.
Key numbers: Data Points – In a study of drug development, Bossart found that one in six Pharma products that start in the market get approved.
There are a total of 197 DDEP have been approved in the period of 2000-2009, an average of 20 per year. The top year for approvals was 2007 with 28 DDEP approved by the FDA.
Share this article with your social network, just click below to share now!
AMPYRA™ APPROVED USING ELAN’S PROPRIETARY MXDAS™ (MATRIX DRUG ABSORPTION SYSTEM) DRUG DELIVERY TECHNOLOGY.
DUBLIN, IRELAND, January 25 2010, Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA™ will be marketed in the U.S. by Acorda Therapeutics (NASDAQ:ACOR).
Using Elan Drug Technologies MXDAS™ technology, AMPYRA™ was developed using a hydrophilic matrix, which controlled the rate of release of dalfampridine through a process of diffusion and erosion in the gastrointestinal tract. Using this technology, consistent therapeutic blood levels can be achieved throughout the dosing period and side effects associated with the immediate release formulations of the drug are potentially reduced. AMPYRA™ is the first New Drug Application (NDA) approved by the FDA for a product using the MXDAS™ technology.
“We wish to congratulate Acorda Therapeutics on the approval of AMPYRA™, which will bring a very important and much needed therapy to the market for MS sufferers,” announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. “This is the second product on which we have worked with Acorda and represents another significant milestone in our successful collaboration with them. It also marks the second product approved by the FDA in the last six months incorporating our technologies and reinforces our position of leadership in drug delivery.”
This is the first medicine approved by the FDA indicated to improve walking speed in people with MS. The approval and subsequent launch of AMPYRA™ therefore may represent an important new addition to MS therapy. Approximately 400,000-500,000 people in the United States have MS, and recent studies indicate that between 64-85% of people with MS have walking disability. Some 70% of people with MS who have walking disability report it to be the most challenging aspect of their disease.
“We are very proud to announce the approval of AMPYRA™ and we thank Elan for their collaboration throughout the development program for this drug. Elan’s expertise in formulation development, which resulted in this extended-release tablet, was a critical component of the AMPYRA™ clinical program,” stated Ron Cohen, MD., President and CEO of Acorda. “Elan has shared our commitment to bringing important new therapies to the market to improve the lives of people with MS throughout the decade we have worked together and we look forward to continuing to find opportunities to work together in the future.”
AMPYRA™ will be manufactured by Elan at its Athlone, Ireland facility, based on an existing supply agreement with Acorda.
About AMPYRA™
AMPYRA™ is a potassium channel blocker approved for the improvement of walking in people with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA™, was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine or 4-AP), which was previously called fampridine. In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AMPYRA™ was developed using Elan Drug Technologies Oral Controlled Release MXDAS™(MatriX Drug Absorption System) technology and will be marketed in the United States by Acorda Therapeutics and by Biogen Idec in markets outside the U.S. AMPYRA™ is manufactured globally by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc at its Athlone, Ireland facility.
About Elan Drug Technologies
Elan Drug Technologies (EDT) a leading drug delivery company is a business unit of Elan Corporation, plc. EDT developed the sustained release formulation of dalfampridine, using one of its Oral Controlled Release Technologies, the MXDAS™ (MatriX Drug Absorption System) technology. Elan Drug Technologies offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. EDT aims to deliver clinically meaningful benefits to patients by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies. Products enabled by EDT technologies are used by millions of patients each day. More information is available at www.elandrugtechnologies.com
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The Company's products include AMPYRA™ (dalfampridine), a potassium channel blocker approved for the improvement of walking in adults with multiple sclerosis (MS), this was demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
AMPYRA™ and Zanaflex Capsules® are trademarks of Acorda Therapeutics Inc MXDAS™ and NanoCrystal® are trademarks of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc.
Safe Harbour/Forward-Looking Statements The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Elan Corporation, plc
Elan Corporation, plc Investors: Chris Burns, 800-252-3526 Chris.Burns@elan.com or David Marshall, 353-1-709-4444 David.Marshall@elan.com
Moderator: Mathias Romacker, Principal Business Analyst, Amgen Tomas Landh, PhD, Director, Strategy & Sourcing, Novo Nordisk A/S Simon Exell, Director, Life Cycle Management, Devices and Formulation, Merck Serono Gerhard Mayer, Director of Marketing and Life Cycle Management, Bayer Schering Jonathan Rigby, Co-Founder & Vice President, Business Development, Zogenix. inc.
Where is needle-free injection going? It will only be adopted if a need is satisfied, and the need must exist. Just like humans have evolved, so has technology. Needle technology has greatly evolved over the last few decades. They’re now more robust systems that can be filled and reused by the patients.
In a large market, many systems will be available. Do they co-exist or compete? The different technologies are addressing different medical needs. They’re demonstrating that they’re meeting patient requirements. Any company could provide many different ways to provide administration. Why? Not all patients are the same, many different patients throughout the world will be using the devices.
It is important that patients adhere to their medications. This is a big problem in the market. Poor outcomes from patients not taking their medicine as prescribed have a large impact. The drug delivery industry can help find a way so that patients find it easy to take their medication, and therefore a more adherent.
Most patients are not willing to pay more for a general delivery system, tradeoffs for less expensive products are a factor, and they expect that biotech generics will begin to appear.
Q: If “the traditional drug delivery model is dead” why should a company with a new needle free technology partner with big Pharma at all?
They should still partner with big Pharma, but also develop the ability to commercialize the product themselves. They develop products within technology. The technology has a capability, you should get an ROI on your technology. You should sell your high value products.
Q: Have needle based technologies peaked or are they advancing? Needle based systems will continue to invest. There are more proteins and products coming to the market that will make this necessary. Competitive environment is stimulating as a whole, so needle and needle-free technology will continue to expand and grow. There are more therapies coming along that could replace these therapies.
Share this article with your social network, just click below to share now!
Annual WALL ST ADDRESS: Retrospective View Over the Past Twelve Months: Analyze the Economy’s Affects on Pharma and Drug Delivery and Prepare with an Outlook for the Future
David Steinberg, Managing Director, Equity Research, Specialty Pharmaceuticals and Drug Delivery Deutsche Bank
The last two years has been interesting and stressful. Things are improving, but it is not clear or not if we are out of the recession. The year is looking up. As for healthcare, in 2008, pricing environment was reasonable and robust, international Rx growth was accelerating. In those stocks, smaller and risky companies weren’t doing well.
Why were healthcare stocks failing to perform? -Investors were in trouble. -Credit markets effectively shut down -Equity financing was virtually non-existent -There was a torrent of mutual funds and hedge fund redemption -Smaller companies bore the brunt of the carnage
In 2008 there were 0 IPOs, in 2009, there were only two. Many companies no longer had to accept financing. Over 180 companies had less than one year’s cash. Now we were looking at a situation where hundreds of companies might go bankrupt.
Rabid Consolidation is a key theme in Pharma sector. There is an unprecedented amount of activity. There were 27 mergers in 2009, 4 were drug delivery companies.
Why? -The bigger the company is the more likely they’re not going to have a great product pipeline. -It’s a great exit strategy for private companies. -Purchases of closely held companies to provide liquidity to a concentrated shareholder base
Who are the buyers? Usually we see branded specialty companies, generic companies, big Pharma, and private equity.
Who are the sellers? -Profitable companies that have competitive/sustainability/critical mass issues -Developmental state companies with attractive late-state pipelines that require major funding to market new products/receive FDA approval for both -Special situations – attractive product partnership economics -The “sweet spot” – profitable companies with market values between $750 mil and $5 billion
Stock Performance – Acusphere, Aradigm, Neopharm, Middlebrook, and many others have had very poor stock performance over the past five years.
Optimized business model (CR model, etc) – stock performance has been very high. Shire, Kos, Adams Respiratory and New River Pharma have done very well.
Live cycle extension products – -Generic drug companies helped change the rules of the game -Managed care has caught on the life cycle extension game
How do you outsmart generics? David advised to start with the product idea and work backwards. Also look at what your company’s product strategy is, in addition to creating an opportunity for settlement. They key is to stay ahead of generics.
Unapproved drugs? Changing FDA regulations There are numerous unapproved drugs on the market if a company does clinical trials on it FDA grants exclusivity to the company
Abbott Tricor example great life cycle strategy Adams Mucinex example Adams pursued NDA on guaifennesin-CR FDA granted exclusivity Naispan Kos examples Abbott acquired Kos for $3.7B in November 2006 Vyvanse New River example a single enantiomer product of adderal a long lifecycle replacement for short duration $1B ADHD Drug
Some of the key recent launched: Vyvance – Shire Intuniv-Shire Lialda-Shire Zenpep-Eurand
Favorite Specialty Pharma stocks in 2010 Large cap- Teva Pharma (Teva), Shire Shire (SHPGY) Mid cap – Bivail (BVF) Small Cap: MAP Pharma (MAPP), Eurand (EURX)
Modest but prolonged recession? Look at these factors for 2010: -Financial -Investor base -Regulatory side -Political side
In 2009, things were very dismal. Now, if a company is looking to borrow money, it is available. The healthcare plan still will be a great influence on how these things work. At the current moment, the stock market could go either way. Companies with strong management teams who are willing to take risks and borrow money, devise some business plans and come up with the right product, they’ll survive and be rewarded with acquisitions and high stock prices among other things.
Share this article with your social network, just click below to share now!
Moderator: Ian Morrison Internationally known Futurist, Future of Healthcare and the Changing Business Environment and author, Health Care in the New Millennium: Vision, Values, and Leadership The Second Curve and Future Tense: The Business Realities of the Next Ten Years Sally C. Pipes, President and Chief Executive Officer, Pacific Research Institute and Author, Miracle Cure: How to Solve America’s Health Care Crisis and Why Canada Isn’t the Answer and The Top Ten Myths of American Health Care: A Citizen’s Guide Michael J. Ruggiero, Senior Director, Government Policy & External Affairs, Astellas Pharma US, Inc. Peter J. Pitts, President, Center for Medicines in the Public Interest and Advisor, Obama FDA Transition Team
Is health reform dead? Understanding healthcare is like unraveling an onion, full of layers and tears. The President made a commitment to healthcare reform. He’s increasing the role fo government in the healthcare system, it currently owns 48%. It’s looking to increase it. It isn’t currently dead, according to the panelists, there are lots of things going on behind doors.
Our country’s leaderships doesn’t know if healthcare reform is dead or not. It’s a continuum rather than a series of options. They look to fix the Senate bill and pass it. A bill may be presented, just scaled back. Healthcare is a part of culture, intertwined with the fabric of society. Healthcare policy is not healthcare reform. Some of the biggest issues we have to tackle (infrastructure, value, etc.), have nothing do with actual reform. Innovation in how hospitals are paid, happens regardless no matter what happens to the current passage of the healthcare bill.
How do we achieve quality healthcare? 1) Patient centered solution 2) Increasing Role for government from 48% to nearly 100%. We would move more towards a Canadian healthcare system.
What about multiple tier systems for healthcare? Canada isn’t the best compression for where the US should get its healthcare from. Holland, France and Germany tend to be the best compression for where US should go. There are rules for the insurance market. Should the US copy Holland? One panelist believes a lot of people look to organize the US healthcare system. As a policy person, it’s difficult to translate the rules. The other panelist believes that all of the systems are undergoing cost control issues. The French system has been facing cost increases, they’re looking at putting people into healthcare education systems. The HMO was making the decision, instead of the patient. However, they’re not making their decision. We need our own healthcare system that suits the needs of America, not the needs of another country. We are world renowned in world for healthcare treatments and devices, we can’t forget that when looking to reform healthcare.
The Drug Delivery industry can help this situation by making it easier to take their medication. That is what they can do to help healthcare reform.
Share this article with your social network, just click below to share now!
Ian Morrison, Internationally known Futurist, Future of Healthcare and the Changing Business Environment and author, Health Care in the New Millennium: Vision, Values, and Leadership The Second Curve and Future Tense: The Business Realities of the Next Ten Years
Every health system in the world is a compromise. They all have flaws. The US has the worst, possibly because we spend twice as much on healthcare than any other nation. Why the difference? The fallacy of excellence – we have great hospitals and technology, but lack in other areas. Can we fix it? Culture is part of the problem. Policy management and the payment system are part of what the problem is in American system.
The average American family cannot afford the average cost of healthcare. The reform to change this is now in jeopardy due to the election of Sen. Brown in Massachusetts. If people are required to buy healthcare, they will be those who cheat the system. The problem with reform is with the stakeholders, most who are onboard with the compromise. Who does the public blame for the problems in the healthcare system? The answers are Pharma and Health insurance.
Extreme right and left feelings have killed reform. Total costs will rise at a slower rate because no coverage expansion subsidized by the government. Rates are going up, no matter what, by 8%. This is without healthcare reform. Could it switch either way? This will result in small businesses getting out priced, just like it has been over the past few decades. There’s no way to balance a budget with a country which has no taxes. The people with the best health plans in America are teachers and firefighters….and those at Goldman Sachs.
Where are we headed? If we stay where we are, generic substitution for drugs will increase. In the 25% of people who are taking injectibles, they don’t take the right amount of medicine due to the current cost. What does this mean for Pharma? Coverage, in Obama’s current plan, would be expanded to cover more drugs. Cost shifting will continue, and it will result in individuals using more generics.
Pharma will have to change the way it does business over the next few years. Value will also have to be demonstrated to the customer at the end.
Share this article with your social network, just click below to share now!
ATLANTA, Ga., January 13, 2010. Altea Therapeutics Corporation (“Altea”) announced today that it has entered into a partnership with KAI Pharmaceuticals, Inc. (“KAI”), a drug discovery and development company, for the preclinical and clinical development of certain KAI proprietary peptides utilizing Altea’s proprietary PassPort® Transdermal Delivery System.
Under the terms of the agreement, Altea and KAI will examine the transdermal delivery of certain KAI proprietary compounds using Altea’s novel transdermal delivery technology, the PassPort System. Altea has also granted KAI an option to receive a worldwide technology license for the further development and commercialization of these novel transdermal products. Should KAI exercise the option, KAI will fund all product development, manufacturing and commercialization activities, and Altea may receive license payments, development and commercialization milestones and royalties on product sales from KAI.
“We are pleased to enter into this agreement with KAI Pharmaceuticals, said Dr. Eric Tomlinson, PhD, DSc, President and CEO of Altea Therapeutics. “The agreement further validates the broad application of the Altea Therapeutics novel transdermal patch technology for the transdermal delivery of water-soluble compounds. While we continue to apply our transdermal technology to currently approved drugs that previously were administered by needle injection or infusion, including water-soluble proteins, carbohydrates and small molecules, this new partnership allows us to apply our technology to the new peptide drugs being developed by KAI Pharmaceuticals.”
Altea Therapeutics is a privately held clinical-stage pharmaceutical company with a proprietary platform technology broadly applicable to the bolus or sustained transdermal delivery of biological drugs (proteins and carbohydrates) that otherwise would be administered by needle injection or infusion. The Company's PassPort® Transdermal Delivery System also is uniquely suited for delivering highly water-soluble low molecular weight drugs that otherwise could not be delivered transdermally.
Altea Therapeutics has partnered with Amylin Pharmaceuticals, Inc. and Eli Lilly and Company to develop and commercialize a novel daily transdermal patch delivering sustained levels of exenatide (currently marketed as Byetta®). The Company also has a partnership with Hospira, Inc. to develop and commercialize a transdermal patch for delivering enoxaparin sodium (currently marketed as Lovenox®) utilizing the PassPort® Transdermal Delivery System.
Altea Therapeutics is also in clinical development of a Transdermal Basal Insulin Patch for diabetes and a Transdermal Fentanyl Citrate Patch for pain. Additional information about Altea Therapeutics may be found at www.alteatherapeutics.com.
KAI is a drug discovery and development company with novel clinical-stage programs in cardiovascular disease, renal complications and pain. KAI’s lead product candidate, KAI-9803, is currently in a Phase 2b study (PROTECTION AMI) designed to assess the effect of KAI-9803 on reducing myocardial injury in heart attack patients. KAI’s second clinical program, KAI-1678, is in Phase 2a studies for pain. KAI’s third program, KAI-4169, is for the treatment of secondary hyperparathyroidism (SHPT) in kidney disease patients and is in IND-enabling studies.
KAI is the leader in the selective modulation of intracellular protein:protein interactions and delivery of peptides into the cell. This approach has broad potential and has been validated clinically. The Company has applied its core expertise to discover highly potent and selective inhibitors and activators for protein kinase C (PKC) isozymes. KAI is based in South San Francisco, California, and can be found online at www.kaipharma.com.
KAI is a registered trademark of KAI Pharmaceuticals.
NOTE: Altea Therapeutics, PassPort, Medicines Made Better. are either registered trademarks or trademarks of Altea Therapeutics Corporation, in the USA and/or other countries. All other brand names, product names or trademarks belong to their respective holders.
The statements in this press release regarding the products of Altea Therapeutics in development, product development plans and projected financial results, are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the ability of Altea Therapeutics to both complete the design, development and manufacturing process development of its products, manufacture and commercialize its products, obtain product and manufacturing approvals from regulatory agencies, manage its growth and expenses, finance its activities and operations, as well as marketplace acceptance of its products.
Share this article with your social network, just click below to share now!
Moderator: Lee Shorter, Director, Biophysical Sensors and Nanomaterials, GSK Pharmaceuticals Robert A. Baughman, PharmD, PhD, Vice President, Experimental Pharmacology, Mannkind Corporation Randolph M. Johnson, PhD,Vice President and Chief of Technology Development, Molecular and Integrative Pharmacology, KAI Pharmaceuticals, Inc. Timothy S. Nelson, President and CEO, MAP Pharmaceuticals Riccardo Panicucci, PhD, Global Head of Chemical and Pharmaceutical Profiling, Novartis Institutes for BioMedical Research Inc. Eric Tomlinson PhD, DSC, President and Chief Executive Officer, Altea Therapeutics Corporation Mary Gardner, Director, Technology Assessment, Hospira, Inc.
As we move through 2010, what will be the effect of the US healthcare plan? There will be an increased and continued financial pressure on emerging biotech and drug delivery. Mergers and acquisitions will continue. Two companies that were major players just last year are no more. There will be a continued pressure of Pharma on the stock market.
The Panel discussion is now open. The first question they’re addressing is: What are some of the key developments from drug deliverers in technology platforms? Rick: In the future, we’re not going to be able to rely on innovative molecules. Molecular innovations need to be coupled with innovative delivery technologies. It would be great for a platform to fit in as many of the platforms as possible.
Randy: What’s important form a small biotech’s perspective is the new opportunity for growth and differentiation. The convergence of new technologies with more new chemical entities can lead to success in the future. There is pricing restrictions and pressure on the Pharma industry, but the blockbuster could still come with new technologies coupled with chemical entities. If we have a enw drug delivery company, maybe they’ll go after a drug that’s already proven. There is a double risk when tehse two things are combined. The regulatory pathway may be a little different, but the merging of technologies could bring new blockbuster drug products to the market.
What is the current value for paring current molecules with new delivery methods? Novartis: Just coming up with blockbusters is not a model going forward. They’re looking at patient-centric ways to move forward. They’re going to look at every good opportunity to find something new to get it into their pipeline across their network. They haven’t always thought this way. They need to have a few game changers that will change up the way they do business, and at the same time, they’re working on many exciting things that will change the way they do business.
How does a company address reimbursement issues for more costly technology? -It has to be attached to patient outcomes. It has to cost less to treat patients effectively. We can better plan clinical trials, so overall, there is a benefit. And Pharma can subsequently getting reimbursed for those things.
Mary: It comes down to a cost/benefit analysis.
What are some of the new opportunities to the developer once one has already successfully transferred a drug to a new delivery platform? -That drug delivery can be enabled. You can develop the product, it’s highly differentiated, the delivery system a higher degree of compliance, you can grow the market and the clinical use of the drug. There is an opportunity for price premium if there is a benefit.
What is the best time to partner on a new technology? When do you need to go to big Pharma? Novartis wants to be part of the development process. For good technologies, they want to make sure they’ll get to the finish line together. Some in Pharma believe that can’t do that anymore, but, they are trying to be more like a biotech company. Their future depends on it. At Novartis, they believe that the earlier the better. It’s on a one by one basis, but if there is an opportunity, Novartis will work on making it a technology.
How can we show insulin you show inhaled insulin taken for a lifetime is safe without a clinical trial that takes a life time without a clinical trial that takes a lifetime? You cannot demonstrate lifetime safety until you’ve had a lifetime. But there are techniques and probability that can change this. Your pulmonary system is constantly fighting off other systems, such as smoking and smog. If someone said that an effective lifetime use of inhaled insulin, we must do everything we can and use all appropriate models, and do a study for the safety of the product. We look at small segments to determine the safety. There is no guarantee, but use all available processes to make the assessment.
Share this article with your social network, just click below to share now!
Peter Kramer, PhD Executive Director, Technology Transactions Bristol-Myers Squibb
Pharma is currently in an unsustainable growth period. The current future is unclear. It’s worth taking the chance in this industry. This industry makes a difference, as AIDS is now a treatable chronic disease. There was also a decrease in cardiovascular disease and survival rates for cancers lasting longer than five years. Kramer is wondering if Pharma is part of the problem or cure? Pharma is an adventure right now, and the 14th Annual DDP is very suited by the magic that Orlando brings. We are all tied together in partnerships. DDP does this for the industry. Collaborative relations and partnerships in drug delivery all make Pharma happen and to be as successful as it is today. With everyone’s participation not only will DDP 14 be a success, but DDP 15 will be even better.
Share this article with your social network, just click below to share now!
Thomas M. Reilly, PhD, MBA President BDHorizons, LLC
Older populations use more drugs, over 2/3 of patients over 65 have chronic diseases. Most patients are taking more than one medicine. Over 125,000 deaths each year are the result of medication mismanagement. Poor compliance also results in poor outcomes and poor quality of life.
Common medication problems in the area -Dysphagia (Difficulty swallowing) -Poor drug absorption from the GI -Xerostomia (dry mouth, often induced by medication) -Polypharmacy – too many drugs
This is in addition to other common problematic symptoms – -Diminished sight/hearing -Impaired stomach/intestinal mobility -Diminished mental faculties -Depression -Poor cooperation -Limited mobility
Advantages of Transdermal Delivery. Many companies are focusing on this for geriatrics, so it is an option for consistent drug delivery to the elderly population. -Exploits large surface area of skin for drug absorption -Transdermal patches provide controlled continuous delivery of drug, while avoiding problems of first pass metabolism and dysphagia associated with oral dosing -Ease of use -Patent acceptability -Caretaker preference
Parkisnon’s Disease -Second most common neurodegenerative disease with average age of onset of 60 -PD symptoms often interfere with oral dosing in patients: dysphagia, gastric stasis, drooling, shaking and tremors and dementia. It’s difficult to continue traditional oral therapy here.
Current medications used to treat this: Exceeded $1.5 billion in sales -Levodopa (converted to dopamine in CNSO -Dopamine agonists (Requip, Mirapex) -MAO-B Inhibitors (selegine) -Anticholinergoics
Urinary Incontinence -Common problem in the elderly affecting up to 35% of the geriatric population -A leading cause of institutionalized among the elderly -Huge economic burden on society
Issues with oral medication – -Associated with high rates of side effects (dry mouth, constipation) which promote poor compliance, especially in the elderly. Compliance in this category are especially low. -Part of the problem with oral oxybutynin is metabolism to active metabolite (N-DEO) in intestine and liver
Advances in formulations and delivery -ER formulations of anticholinergics for once-a-day dosing -Oxytrol ®: Transdermal patch from Watson. It delivers oxybutynin continuously over 3-4 days. Skin irritation has been the main problem. It’s resulted in the creation of a gel.
Age-related macular degeneration (ARMD) -Leading cause of vision loss and blindness in the elderly -Affects up to 10 million Americans, with epidemic proportions expected by 2040 due to demographics -Wet and dry forms Dry is the most common, it’s really the precursor. No way to prevent this to the conversion of the wet form. It occurs in the back of the eye, so it’s very difficult to deliver blood there. Current treatments require interval injections.
-Addressing medication problems in the elderly offers huge potential for both societal and economic gains.
Share this article with your social network, just click below to share now!
Growth from injectables will mitigate the generic-driven decline of the dominant oral drug segment
Delivery technology can readily enhance the therapeutic value of a drug and, in doing so, helps companies add commercial value across all stages of the drug lifecycle. Physiochemical (e.g. controlled release, bioavailability enhancers) and biomolecular (e.g. protein/peptide, lipid vehicle) delivery platforms are the most prevalent in the drug delivery space, while in terms of route of administration, orals and injectables make up more than 80% of the prescription pharmaceutical market, which is also reflected in their prominence in the delivery technology space.
Looking at the leading prescription pharmaceutical companies, Datamonitor expects there to be a shift in market share away from orals and towards injectable drugs out to 2014. Injectables will see an increase in annual sales of $49 billion over 2008– 14, whereas annual sales from oral drugs will decline $10.9 billion. This reflects a number of underlying factors driving each delivery type, such as therapeutic focus, molecule type and lifecycle stage. On the whole, companies overly exposed to oral therapeutics will see weak sales growth over the forecast period, whereas companies positioned in the injectable drug segment will exhibit the fastest growth out to 2014.
Use this new report to: • Assess how drug delivery has become an ever present feature in the business model of the leading pharmaceutical companies • Provides an insight into the prominent technology types in the expansive drug delivery segment • Benchmarks the sales performance of the leading prescription pharmaceutical companies in terms of drug delivery
Case Studies: Creating Novel Therapeutics with Superior Potency, Duration of Action and Unique Delivery Potential by Harnessing Second Generation Dicer Substrate RNAs (DsiRNAs) Sujit K. Basu, PhD Senior Director, Formulation Dicerna Pharmaceuticals, Inc.
siRNA Delivery Options Flexible delivery of DsiRNAs Multiple delivery options:
DsiRNA uses natural gene silencing pathway – optimized for mammalian cells -Stringest screening criteria and molecular architecture produce highly specific DsiRNAs, -High potency low dose, long duration of action (infrequent dosing observed) -Immunostimulatory events can be abrogated by appropriate chemical modification
Share this article with your social network, just click below to share now!
Danchen Gao, PhD Director, New Drug Development Anchen Pharmaceuticals, Inc
Controlled release dosage forms – -Administer in high dose at given time -Repeat dose in several hours
It is independent of the delivery conditions. For sustained release dosage form, the drug will provide a prolonged release. The release rate may be significantly effected by the delivery conditions.
Types of controlled release systems: Oral solid dosage forms (18% of market), Orla liquid dosage forms, depot and liposomes.
Common oral solid controlled release polymeric systems 0 matrix system, reserve system, osmotic pump system
Swellable matrix tablets – incorporate drug into polymer matrix. It’s activated by water penetration, lower glassy rubbery temperature, polymer relaxation and swelling, polymer forms gel layer on tablet surface, polymer and drug dissolution. The gel layer is the key for drug release. It holds drug release rate and prevents matrix discentigration.
Reservoir system – Film coated table or multi-particles. Transport of drug through a network of capillaries filled with dissolution of media. The transport of drug through hydrated swollen film.
Osmotic pump – encased by a semi permeable membrane with an orifice – Water penetrates through the membrane into the tablet core containing osmotic particles and drug. Drug release is via the orifice and controlled by osmotic pressure formed in the tablet. Drug release rate is independent of drug properties and release environment. Offers zero-order release
Oral CR Delivery System Selection -Drive by market – product differentiation vs. margin. Which stage are you entering into the market? Is it first generation, or extending the patent life of the drug? -Drive by drug properties – The chemical properties. Is it soluble or insoluble? Is it stable? The ideal can. -Drive by dose strength – Matrix or coded beas? What is the release profile, it’s easy to adjust the dose. For the matrix tablet, the processing cost is low, but there is a lot of competition.
Design: -Complex an ionic or ionizable drug using ion exchange resigns -Provide controlled release using polymer coating -Great for taste masking
Suitable drug candidates: -Positive change in structure -Freely soluble in water -Chemically stable in aqueous conditions -Has good complexion efficiency -Prefer with UV absorbance Example of system that successfully used this – Pennkinetic system
Challenges of the Aqueous Coating Systems – -Smaller particle size than beads in solid dosage form -Require hydrophic polymers with high flexibility
Oral Liquid CSR -Geriatric and pediatric market -Limited by drug properties and drug loading -Overcome coating and stability challenges -In vivo-in vitro correlation
Share this article with your social network, just click below to share now!
Over 45% of all new indication approvals granted by the FDA since 1998 belong to drugs that fall in the Genito-urinary system and Nervous system.
Optimizing Lifecycle Management, a best selling report explains the basics of drug lifecycle and investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via FDCs.
The need to derive the maximum commercial mileage from all components of a drug company’s portfolio is clearly evident in an era of falling returns on investment and higher capital costs. This best selling report investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via fixed dose combinations.
The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to provide a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world. An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.
Gain an understanding of legal provision for patent protection and data exclusivity and understand their role in the context of product lifecycle management with this report from Business Insights, market leaders in strategic business information. Click here for more information on this title.
Share this article with your social network, just click below to share now!
Technology: The patented Topi-Click topical dosing applicator (TDA)
“Dose it easy and quick with Topi-Click.”
"We don’t put deodorant on with our hands so why do we ask patients to put topical meds on with their hands." The patented Topi-Click topical dosing applicator (TDA) provides a pill bottle’s ease of use with the dosing precision of syringes to solve this problem. Topi-Click provides an integrated applicator pad with a metered dosing clicker to overcome the non-compliance procedure of having to rub topical meds onto treatment areas with the hands. We know the hand is a great absorber of topicals; therefore, the patient is using the treatment area to rub a large percentage of the medicine into their hands. Using the hands can also increase chances of others accidentally being exposed to someone else’s prescription when holding or shaking hands. Very recently, a male topical testosterone drug was delayed approval by the FDA due to the concern of transference of prescription topicals to others. The Topi-Click directly addresses these concerns with needed innovation.
In addition, the audible clicker and tactile dosing feedback features of the Topi-Click allow patients to dispense a metered dose in a matter of seconds…even in complete darkness. The Topi-Click TDA protects the public and the drugs’ success with features that help promote and attain compliance. With easier compliance comes more treatment success, thus also protecting profitability. Next, by combining patented dosing applicator technology with custom designer bottle shapes, pharmaceuticals are differentiated and pipelines are guarded. Custom Rx TDA deserves to win because they help solve the growing topical dosing challenges with Topi-Click’s laser focused innovation of features: 1.Applicator Pad; 2. Audible & Tactile Feedback of Metered Dosing; 3. Innovative Shape and Design for Recognition. See clips of highlights from Oprah, Dr. Phil and The Doctors that demonstrate its use with hormone prescriptions at www.Topi-Click.com
Share this article with your social network, just click below to share now!
DosePro™- the world’s first & only single use, easy to use, disposable, needle free injection system that removes the anxiety associated with a fear of needles Zogenix is a showcase example of a Specialty Phama Co with a foundation in Drug Delivery. Since inception in late 2006, Zogenix has raised $170MM in private capital, acquired and developed a unique drug delivery technology in combination with a drug product through full clinical development, NDA approval and U.S. launch. Zogenix drug delivery technology is called – DosePro™- the world’s first & only single use, easy to use, disposable, needle free injection system that removes the anxiety associated with a fear of needles. Zogenix made history in July 2009 when the U.S. FDA-approved the company’s NDA for the very first product ever that utilizes a pre-filled needle-free injection technology for the treatment of migraine and cluster headaches; SUMAVEL DosePro (sumatriptan for injection). A brief list of Zogenix achievements are below:
• Acquired and completed development of the DosePro single use, needle free injection technology. • In licensed a single entity oral Hydrocodone product for pain that utilizes Elan’s SODAS controlled release drug delivery technology – Phase 3 initiation in Q1 2010. • Licensed SUMAVEL DosePro to Desitin Pharma for commercialization in Europe. Desitin completed the pivotal registration study for SUMAVEL DosePro and filed for approval in Europe in October 09. • July 09, the U.S. FDA approved the NDA for SUMAVEL DosePro • August 09, signed U.S. co-promotion agreement with Astellas Pharma U.S. • January 2010 U.S. launched SUMAVEL DosePro with Zogenix Neurology Sales force and Astellas Pharma Primary Care Physician Sales force.
Partnership: Excellence in company partnering strategies
The in-licensing team headed by Dr. Harvinder Popli has entered into 44 agreements in the last 5 years of operation. In-licensing as a function started in Ranbaxy in 2005. The agreements have been signed with innovation/technology driven companies from US, Europe and Asia. The deals were done primarily for the Indian market along with markets like Singapore, Malaysia, Vietnam, Cambodia, Myanmar, Philippines, Sri Lanka & in the Middle East region. The deals were signed in therapy areas of Clinical Dermatology, Asthetic Dermatology, CNS, Urology, Oncology, Pain Management, Neutraceuticals, Dental products, Respiratory etc. The in-licensing team is also responsible for pre-launch and project management activities for launching the licensed products within stipulated timelines. As a recognition to her unmatched passion and hard work, recently Dr. Harvinder Popli has been nominated as one of the top 20 business development professionals in the reputed European Business Development newsletter, EuroPlx Business Developer Nov/Dec'2009 edition; weblink.
Eurand is nominated for the Partnering Excellence based on a partnership deal that Troy Harmon did with GSK. In this alliance, Eurand created optimal value for the partnering by being very sensitive to the needs and required time lines of the partner. Extraordinary efforts were made by both parties to quickly negotiate the deal and by Eurand to quickly execute on the development plan. The product, Lamictal ODT, went from agreement signature to NDA submission in only 19 months! The entire process was highly iterative throughout development and the parties had extensive communication throughout to achieve excellent results in a very short timeline. The excellent relationship between the two companies is further supported by a recent panel at a 2009conference where the parties participated together in discussing the value of drug delivery partnerships.
Technology: a novel Nanoparticle which offers unique targeted in vivo delivery of nucleic acids into Antigen Presenting Cells (APC) resulting in robust / protective immune responses.
The platform is not only ideal for “Genetic Vaccination” as it targets APC and activates helper T cells, it, incidentally, may be used as delivery of nucleic acids including siRNA into such mononuclear cells which has broad therapeutic applications. Wallace H. Coulter Center of the University of Miami is a technology development center for biomedical innovation. WHCC is unique in acting as a catalyst for moving innovative University of Miami research with commercial potential from the bench to industry.
Technology: Novel bone-targeting drug delivery technology
Pradama Inc. is a pharmaceutical company that creates multiple products for bone diseases and disorders using its novel bone-targeting drug delivery technology. Bone tissue is distinguished from other tissues by the presence of bone mineral, mainly hydroxyapatite. Pradama's bone-targeting agents have significant affinity for hydroxyapatite. Pradama’s bone-targeting agents have several advantages over other bone-targeting approaches, including; oral availability, therapeutic inactivity, stability and flexibility.
Isis Biopolymer, Inc., founded in 2006, is led by a team of experienced scientists and entrepreneurs accomplished at successful development and commercialization of medical devices, materials and systems design. The company has developed a major advance in intelligent non-invasive transdermal drug delivery, the IsisIQ™ Patch. The patch is a fully programmable, single-use, “band-aid-like” active patch that controls and monitors transdermal drug delivery; ensuring safe and accurate administration through the skin using iontophoresis. An innovative solution to the challenges of today’s transdermal drug delivery systems, the IsisIQ™ Patch features a proprietary selective barrier membrane that facilitates the transport or complete cessation of drug molecules through the skin. Drug transport can be modulated for up to three drugs per patch and is fully programmable for customized delivery and monitoring via an integrated wireless communication platform. The unique single electrode design eliminates variability in drug delivery that can occur with changes in the skin due to temperature, moisture and movement; preventing inadvertent or over delivery of drug. The IsisIQ™ Patch is also a biosensor that can detect skin emanations, which may be indications of medical events such as heart attached, shock or diabetic reactions. Breakthroughs in pliable polyester substrate and hydrogels support lower cost development and manufacturing, as well as a more diverse range of delivery of drugs than is currently available. Moving forward, Isis Biopolymer technology will expand the worldwide multi-billion dollar market for transdermal delivery of existing and drugs in development for pain management, oncology, neurology, endocrinology, cardiovascular, CNS disorders, as well as therapies for chronic and acute conditions. Isis Biopolymer has developed not only the technology to revolutionize transdermal drug delivery, but also make it affordable as a result of our materials and manufacturing processes based here in the United States. Isis is focused on providing revolutionary (and cost-effective) transdermal drug delivery and biosensors to improve patient compliance and generate better health care outcomes.
Value Creation: Halozyme’s EnhanzeTM Technology for improvements patient-centric dosing
Halozyme’s EnhanzeTM Technology is a novel drug delivery platform designed to increase the subcutaneous absorption of biologics and to convert biologics from intravenous to subcutaneous route of administration. Two products utilizing EnhanzeTM Technology entered Phase III studies in 2009, creating significant value for the pipelines of Halozyme’s partners. As part of the Halozyme-Roche collaboration, subcutaneous formulation of HERCEPTIN® (trastuzumab) with EnhanzeTM entered a Phase III study in 2009. HERCEPTIN® is currently administered intravenously. EnhanzeTM Technology is anticipated to allow patients with HER2-positive breast cancer to administer HERCEPTIN® themselves with or without the support of a healthcare professional via a simple subcutaneous injection.
As part of the Halozyme-Baxter collaboration, subcutaneous GAMMAGARD® Liquid [Immune Globulin Intravenous] 10% (IGIV) with EnhanzeTM Technology entered a Phase III study in 2009. GAMMAGARD® is currently administered intravenously. Subcutaneous administration of GAMMAGARD® with EnhanzeTM could allow patients to receive a full monthly dose in a single injection site in their home setting, in contrast to other subcutaneously administered immune globulin products that require weekly administration at multiple injections sites simultaneously.
